WO2020073840A1

WO2020073840A1 - Flexible pad, breathing cover structure, and breathing interface

Info

Publication number: WO2020073840A1
Application number: PCT/CN2019/108851
Authority: WO
Inventors: 雷明初; 李颖颖
Original assignee: 深圳瑞之谷医疗科技有限公司
Priority date: 2018-10-12
Filing date: 2019-09-29
Publication date: 2020-04-16
Also published as: CN109172977A

Abstract

Provided is a flexible pad (103), detachably arranged on a cover (102) of a breathing interface apparatus; a peripheral edge of one end of the cover (102) extends laterally inward to form a sealing pad; an opening (101) is formed around the sealing pad; the flexible pad (103) has a three-dimensional configuration and matches the three-dimensional contour of the sealing pad to form a double-layered pad structure. The flexible pad (103) is such that the wearing effect of the breathing cover structure (10) is better; also provided are a breathing cover structure (10) and a breathing interface.

Description

Flexible cushion, breathing shell structure and breathing interface interface

Technical field

The invention relates to a flexible cushion, a breathing shell structure and a breathing interface interface.

Background technique

In the treatment of sleep-related respiratory diseases such as obstructive sleep apnea, positive pressure ventilation therapy is generally used, that is, positive pressure gas is delivered to the patient's respiratory airway through a respiratory device. Such breathing equipment generally includes a positive pressure ventilation device (CPAP, Continuous Positive Airway Pressure) or a bi-level positive pressure ventilation device (Bi-PAP, bilevel positive airway pressure), an air delivery tube, and a mask. The mask generally includes a joint, an elbow, a shell, a flexible mask, a strap, and a bracket connected to the air delivery pipe. The joint, the elbow, the casing and the flexible cover are connected in sequence, the bracket is fixed on the casing, and both ends of the strap are snapped on the bracket. When in use, the mask is fixed on the nose or mouth and nose area of the patient by the strap. Under the effect of the pressure difference between the inside and outside of the strap and the nasal mask, the flexible shell and the skin of the joint area form an airtight and positive pressure The gas is delivered into the patient's respiratory airway. During use, the comfort, stability, and sealing effect of the face mask and skin contact are three very important indicators that will directly affect the patient's experience and treatment effect.

Commonly used face masks or nasal masks are made of silicone materials that are in contact with the skin. Silicone materials have the following problems when they are in direct contact with the skin: Silicone is a hydrophobic and oleophobic material with poor breathability, almost no oil absorption, moisture absorption and perspiration Function, when wearing a face mask or nasal mask for a long time, the sweat and grease metabolized by the wearer's face skin cannot be effectively discharged, and the face skin that has been in contact with the face mask or nasal mask for a long time under pressure load will be prone to severe red marks, even Local skin ulcers, etc., which makes the wearing experience bad, affects the treatment effect and the patient's compliance with positive pressure ventilation treatment.

Summary of the invention

Based on this, it is necessary to provide a flexible cushion with better wearing effect, a breathing shell structure and a breathing interface interface.

A flexible gasket is detachably provided on a casing of a respiratory interface interface device, and a peripheral edge of one end of the casing extends laterally inward to form a sealing gasket, and the sealing gasket surrounds to form an opening, and the flexible gasket It has a three-dimensional configuration and coincides with the three-dimensional contour of the sealing gasket to form a double-layer gasket structure.

In one embodiment, the material of the flexible pad is elastic fabric, or PU sponge, or a composite material of elastic fabric and sponge, or a composite material of elastic fabric and PU film, or a laminated adhesive layer, PU sponge layer and elastic fabric.

In one embodiment, the elastic fabric is a heat-settable elastic fabric, which includes the following components: nylon, Lycra yarn, absorbent fiber, and hot melt yarn.

In one embodiment, the elastic fabric is an elastic sandwich cloth, and the thickness of the flexible cushion is 0.4-5 mm.

In one embodiment, the sealing pad is formed with a bonding area, the sealing pad is a silicone pad, and the flexible pad is used to at least partially cover the bonding area.

In one of the embodiments, the flexible pad is formed with a skin contact area that directly contacts the skin, and the skin contact area and the bonding area at least partially overlap.

In one embodiment, the surface of the flexible liner is coated with an adhesive layer, and the flexible liner is detachably attached to the bonding area through the adhesive layer. The adhesive layer is Gel layer or self-adhesive layer.

In one embodiment, the flexible gasket includes an annular main body and an annular peripheral edge formed on the peripheral edge of the annular main body, the annular peripheral edge of the flexible gasket is detachably connected to the casing and Around the sealing gasket, the ring-shaped body and the sealing gasket are separated from each other.

In one of the embodiments, a groove is formed on the casing, and an elastic member is provided on an annular periphery of the flexible gasket, and the elastic member is detachably snapped in the groove.

In one embodiment, the flexible gasket further includes a hard snap ring, the hard snap ring protrudes outwardly around the outer edge of the skin contact area, and a loop is protruded on the hard snap ring Shaped frame, a ring-shaped groove is recessed on the cover, the ring-shaped groove is wrapped around the outside of the bonding area and is spaced apart from the bonding area, and the hard snap ring is sleeved and attached On the side wall surface of the casing, the ring-shaped frame is detachably snapped into the annular groove to install the flexible gasket on the casing.

In one embodiment, the flexible pads are thickened on opposite sides of the nose bridge.

A breathing shell structure, including a sealing gasket and the flexible gasket as described above, the sealing gasket is integrally formed on the housing, and a peripheral edge of one end of the housing extends laterally inward to form the sealing gasket An opening is formed around the sealing gasket, and the flexible gasket is detachably disposed on the casing and at least partially covers the sealing gasket.

In one embodiment, the sealing gasket is a silicone gasket, a bonding region is formed on the sealing gasket, the flexible gasket at least partially covers the bonding region, and the flexible gasket is formed with a The skin contact area where the skin directly contacts.

In one embodiment, the flexible gasket is partially attached and connected to the sealing gasket.

In one of the embodiments, a nose bridge contact area is formed on the joint area, the flexible pad includes an attachment portion and a separation portion connected to each other, the attachment portion is detachably connected to the nose bridge contact area, The separation part and the bonding region are separated from each other, and the skin contact region is formed on the attachment part and the separation part.

In one embodiment, the flexible pad covers only the nose bridge contact area.

A breathing interface interface includes the breathing shell structure as described in any one of the above.

In one embodiment, the respiratory interface interface is a face mask, nasal mask, or mask.

Since the flexible cushion has a three-dimensional configuration and coincides with the three-dimensional contour of the sealing cushion to form a double-layer cushion structure, the flexible cushion is located between the shell and the skin of the wearer's face and is compressible Deformation, load distribution, avoid local stress concentration (especially the nose bridge), thereby significantly improving the wearing comfort, making the wearing of the breathing shell structure better.

In addition, it is made of elastic fabric or PU sponge, and these two materials are porous or mesh-structured materials, which have better cushioning characteristics and have the functions of moisture absorption, perspiration, skin-friendly and cushioning, so that the breathing mask When the shell structure is in contact with the skin, the flexible liner is in direct contact with the wearer's skin, and the hydrophilic, oil-absorbing, moisture-permeable, and sweat-wicking properties of the flexible liner can reduce the risk of red marks and skin damage. .

BRIEF DESCRIPTION

FIG. 1 is a schematic perspective view of a nasal mask according to an embodiment.

FIG. 2 is a perspective exploded view of the nasal mask shown in FIG. 1.

Fig. 3 is a partially cutaway perspective view of the nasal mask shown in Fig. 1.

FIG. 4 is a partially enlarged view at A in FIG. 3.

5 is a schematic perspective view of an embodiment of a flexible gasket.

detailed description

In order to facilitate understanding of the present invention, the present invention will be described more fully below with reference to related drawings. The drawings show preferred embodiments of the present invention. However, the present invention can be implemented in many different forms and is not limited to the embodiments described herein. On the contrary, the purpose of providing these embodiments is to make the disclosure of the present invention more thorough and comprehensive.

It should be noted that when an element is said to be “fixed” to another element, it can be directly on the other element or there can also be a centered element. When an element is considered to be "connected" to another element, it may be directly connected to another element or there may be a centered element at the same time. The terms "vertical", "horizontal", "left", "right" and similar expressions used herein are for illustrative purposes only and are not meant to be the only embodiments.

Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the technical field of the present invention. The terminology used herein is for the purpose of describing specific embodiments and is not intended to limit the present invention. The term "and / or" as used herein includes any and all combinations of one or more related listed items.

Please refer to FIGS. 1 to 4, a nasal mask 100 includes an elbow assembly 11, a bracket 12, a casing 13, a casing 102 and a flexible cushion 103. The bracket is fixed on the casing 13, and the elbow assembly 11 passes through the bracket 2 and is fixedly connected to the casing 13. The housing 102 is connected to a side of the housing 13 facing away from the bracket 12, wherein the housing 102 and the housing 13 together form a cavity 30 for receiving the nose of the wearer, the housing 102 is located at An opening 101 is formed on the side away from the housing 13. Wherein, a sealing gasket is formed on one side of the casing 102, the casing 102 is fixed on the casing 13, and the flexible gasket 103 is disposed on the casing 102 away from the casing 13 One side is arranged on the sealing gasket. The sealing gasket and the flexible gasket 103 together constitute a respiratory shell structure 10.

For example, the sealing gasket and the flexible gasket 103 are detachably connected together. In another embodiment, the sealing gasket is integrally formed on the housing 102, and the sealing gasket and the gasket The flexible pads 103 are fixedly connected together. The cover 102 is made of silicone, and its Shore hardness is about 40 degrees. The casing 10 is provided with the sealing gasket around the edge of the opening 101, and the sealing gasket extends laterally inward along the peripheral edge of the casing 102, and a bonding region 1011 is formed thereon. The periphery of the opening 101 extends to the maximum contour of the housing 102, and the bonding area 1011 will directly or indirectly contact the wearer's facial skin when worn.

For example, the flexible gasket 20 has a three-dimensional configuration, and an opening is provided in the middle to match the opening 101 on the casing 10, and its contour matches the three-dimensional contour and size of the bonding area 1011 on the sealing gasket , The two are superimposed or combined together to form the breathing shell structure 10. For example, the flexible pad 20 is disposed on the housing 102 and at least partially covers the bonding area 1011 to form a skin contact area 201 on the flexible pad 20 that directly contacts the skin. The material of the pad 20 is an elastic fabric (knitted warp-knitted or weft-knitted elastic fabric with no loose edges) or PU (polyurethane, polyurethane) sponge (compression rate> 60%, elongation rate> 30%, and stretch recovery rate> 95% , High tear strength).

When wearing the nasal mask 100, the nose of the wearer is accommodated in the cavity 30, and the skin contact area 201 of the flexible pad 20 directly contacts the skin of the wearer's face. Since the flexible pad 20 has a three-dimensional configuration, it is made of elastic fabric or PU sponge, and these two materials are porous or mesh-structured materials, which have better cushioning characteristics, and have moisture wicking, affinity Skin and cushion functions, so that when the breathing shell structure 10 is in contact with the skin, the flexible pad 20 directly contacts the wearer's skin, using the flexible pad's hydrophilic, oil-absorbing, moisture-permeable and sweat-wicking properties, Can reduce the risk of red marks and skin damage. Moreover, the flexible cushion 20 is located between the shell 102 and the skin of the wearer's face. The breathing shell structure 10 has a better wearing effect.

For example, the bonding area 1011 partially extends laterally to form a suspension structure to partially block the flow direction of the air flow in the cavity 30. Due to the low compressibility in the thickness direction of the housing 102, the cushioning effect of the material is poor and cannot be effective The load applied to the skin of the wearer's face is dispersed, and the flexible pad 20 is attached to the suspension structure, and its extension direction is perpendicular to the thickness direction of the housing 102, so the suspension can be used The structural flexible cushion improves the deformation degree of the flexible cushion 20 on the bonding area 1011 in the direction of the air flow in the housing 102, and improves the cushioning effect.

In order to improve the cushioning effect of the flexible pad 20, the elastic fabric is a heat-settable elastic fabric, which includes the following components: nylon, lycra yarn content, hygroscopic fiber, and hot melt yarn. Specifically, the elastic fabric is an elastic sandwich cloth, and the thickness of the flexible liner 20 is 0.4-5 mm, and the preferred range is 0.4-0.2 mm. By providing the flexible pad 20 with the above components, the cushioning and moisture absorption effects can be improved.

For example, the casing 102 is a silicone casing, and the flexible gasket 20 is detachably attached to at least a part of the bonding area 1011 of the sealing gasket. For example, a surface of the flexible gasket 20 facing the housing 102 is coated with an adhesive layer, and the flexible gasket 20 is detachably attached to the bonding area 1011 through the adhesive layer. The adhesive layer is a gel layer or a self-adhesive layer. By setting the flexible gasket 20 to have a different composition from the casing 102, a double-layer composite sealing gasket structure is formed, so that the supporting effect of the casing 102 is exerted, and at the same time, the flexible gasket 20 can be utilized The contact flexibility of the breathing shell structure 10 with the skin is improved. By providing the adhesive layer, the replacement of the flexible gasket 20 is facilitated.

For example, in an embodiment, a nose bridge contact area 1013 is formed on the bonding area 1011, and the flexible pad 20 includes an attachment portion 21 and a separation portion 23 connected to each other, and the attachment portion 21 faces the The surface is coated with an adhesive layer, the attachment portion 21 is attached to the nose bridge contact area 1013, the separation portion 23 is separated from the bonding area 1011, and the skin contact area 201 is formed on the attachment Part 21 and the separation part 23 above.

In another embodiment, the flexible sealing gasket 20 includes an attaching portion 21 and a separating portion 23 connected to each other. The attaching portion 21 is located on an edge of the side away from the opening thereof. The upper edge of the area is attached by contact, the separation portion 23 is separated from the bonding area 1011, and the skin contact area 201 is formed on the attachment portion 21 and the separation portion 23.

For example, a frame (not shown) is provided on the attachment portion 21, and the frame fixes the attachment portion 21 and the nose bridge contact area 1013 together. For example, in another embodiment, the frame detachably connects the attachment portion 21 and the nose bridge contact area 1013 together. By providing the separating portion 23, the flexible gasket 20 can be connected and separated from the casing 102 more conveniently. For example, in another embodiment, a nose bridge contact area 1013 is formed on the bonding area 1011, and the flexible pad 20 only covers the nose bridge contact area 1013. In this case, the flexible pad 20 Less materials are used, and the manufacturing of the respiratory shell structure 10 can be facilitated. When wearing the respiratory mask, the stress on the nose bridge is relatively concentrated. This structure can relieve and disperse the compressive stress in the contact area of the nose bridge, and improve the wearing comfort.

For example, the present invention provides a nasal mask including the breathing shell structure 10. For example, the above-mentioned breathing shell structure 10 can also be applied to a face mask. The present invention also provides a face mask including the breathing shell structure 10 according to any one of the above. The manufacturing method of the face mask is specifically as follows: three-dimensionally forming a planar fabric into a prefabricated fabric component; silica gel is sprayed on the inner surface of the prefabricated fabric component to cover the gap of the fabric yarn to form an air-impermeable fabric silicone composite gasket; Placed in an injection mold, over-injected to form the mask body to obtain an integrated composite sealing gasket. The following process methods can also be used: (1) Foam cavity is used to make a three-dimensional flexible liner made of polyurethane sponge; (2) The polyurethane flexible liner is placed in a liquid silicone injection mold and formed by secondary molding The main body of the mask obtains an integrated composite sealing gasket.

For example, the present invention provides a flexible cushion 20 used for a face mask or a nasal mask. The face mask or a nasal mask includes a shell 102, and a bonding area 1011 is formed on one side of the shell 102. The flexible pad 20 is used to be disposed on the housing 102 and at least partially covers the bonding area 1011 to form a skin contact area 201 on the flexible pad 20 that directly contacts the skin. The pad 20 has a three-dimensional configuration, and its material is elastic fabric or PU sponge. For example, in an embodiment, the present invention also provides a method for manufacturing the flexible gasket 20. The method for manufacturing the flexible gasket 20 includes the following steps: applying liquid silica gel or gel on one side of the fabric; Three-dimensional vulcanization molding of the fabric; and cutting the fabric along the outline according to a preset to make the flexible cushion. Through the setting of the above manufacturing method, the flexible pad 20 can be more conveniently installed on or removed from the housing 102.

Referring to FIG. 5, the flexible gasket 103 in one embodiment includes a ring-shaped main body 1031 and a ring-shaped peripheral edge 1033 formed on the periphery of the ring-shaped main body. The ring-shaped peripheral edge of the flexible gasket is detachably connected to the On the casing and surrounding the sealing gasket, the ring-shaped body and the sealing gasket are separated from each other. A groove is formed on the cover shell, and an elastic member 1035 is provided on the annular peripheral edge of the flexible gasket, and the elastic member is detachably snapped in the groove.

For example, the present invention provides a flexible gasket, which is used to be detachably disposed on a sealing gasket of a housing, the flexible gasket is of a three-dimensional configuration and has a three-dimensional contour with the sealing gasket Match to form a double-layer cushion structure, the material is elastic fabric or PU sponge. In one embodiment, a clamping groove is concavely formed on the bonding area, and an insertion portion is convexly formed on the flexible gasket, and the insertion portion is detachably inserted into the clamping groove.

For example, the present invention provides a flexible gasket. The flexible gasket is detachably disposed on the housing of the respiratory interface interface device, and a peripheral edge of one end of the housing extends laterally inward to form a sealing gasket, the sealing gasket surrounds to form an opening, and the flexible gasket is The three-dimensional configuration matches the three-dimensional contour of the sealing gasket to form a double-layer gasket structure. The material of the flexible pad is an elastic fabric, or a PU sponge, or a composite material of an elastic fabric and a sponge, or a composite material of an elastic fabric and a PU film, or a laminated adhesive layer, a PU sponge layer, and an elastic fabric. The elastic fabric is a heat-settable elastic fabric, which includes the following components: nylon, Lycra yarn, hygroscopic fiber, and hot melt yarn. The elastic fabric is an elastic sandwich cloth, and the thickness of the flexible pad is 0.4-5 mm. A bonding region is formed on the sealing gasket, the sealing gasket is a silicone gasket, and the flexible gasket is used to at least partially cover the bonding region. A skin contact area that directly contacts the skin is formed on the flexible pad, and the skin contact area and the bonding area at least partially overlap. An adhesive layer is coated on the surface of the flexible liner, the flexible liner is detachably attached to the bonding area through the adhesive layer, the adhesive layer is a gel layer or a sticker Floor.

For example, the flexible gasket includes an annular main body and an annular peripheral edge formed on the peripheral edge of the annular main body, the annular peripheral edge of the flexible gasket is detachably connected to the casing and surrounds the sealing liner Pad, the ring-shaped body and the sealing gasket are separated from each other. A groove is formed on the cover shell, and an elastic member is provided on an annular peripheral edge of the flexible gasket, and the elastic member is detachably snapped in the groove. The flexible gasket further includes a hard snap ring, the hard snap ring protrudes outwardly around the outer edge of the skin contact area, a ring-shaped frame protrudes from the hard snap ring, and the cover The upper concave is provided with a ring-shaped groove, the ring-shaped groove is wrapped around the outer side of the bonding area and spaced apart from the bonding area, and the hard snap ring is sleeved and attached to the side of the cover On the wall surface, the ring-shaped frame is detachably snapped into the annular groove to install the flexible gasket on the casing. The flexible pads are thickened on opposite sides of the nose bridge.

For example, the present invention provides a breathing shell structure, including a sealing gasket and the flexible gasket according to claim 1, the sealing gasket is integrally formed on the shell, and one end of the shell is circumferentially oriented The sealing gasket extends inside to form an opening around the flexible gasket. The flexible gasket is detachably disposed on the casing and at least partially covers the sealing gasket. The sealing gasket is a silicone gasket, a bonding region is formed on the sealing gasket, the flexible gasket at least partially covers the bonding region, and a skin contact region that directly contacts the skin is formed on the flexible gasket . The flexible gasket is partially attached and connected to the sealing gasket. A nose bridge contact area is formed on the bonding area, and the flexible pad includes an attachment portion and a separation portion connected to each other, the attachment portion is detachably connected to the nose bridge contact area, the separation portion and the The bonding areas are separated from each other, and the skin contact area is formed on the attachment portion and the separation portion. The flexible pad covers only the nose bridge contact area.

For example, a groove is formed on the cover, and an elastic member is provided on an annular peripheral edge of the flexible gasket, and the elastic member is detachably snapped in the groove. For example, the present invention also provides a breathing interface interface, including the breathing shell structure as described in any one of the above. In one embodiment, the respiratory interface interface is a face mask, nasal mask, or mask.

The technical features of the above-mentioned embodiments can be arbitrarily combined. To simplify the description, all possible combinations of the technical features in the above-mentioned embodiments are not described. However, as long as there is no contradiction in the combination of these technical features, All should be considered within the scope of this description.

The above-mentioned embodiments only express several embodiments of the present invention, and their descriptions are more specific and detailed, but they should not be construed as limiting the patent scope of the present invention. It should be noted that, those of ordinary skill in the art, without departing from the concept of the present invention, can also make several modifications and improvements, which all fall within the protection scope of the present invention. Therefore, the protection scope of the invention patent shall be subject to the appended claims.

Claims

A flexible gasket, characterized in that the flexible gasket is detachably provided on a housing of a respiratory interface interface device, and a peripheral edge of one end of the housing extends laterally inward to form a sealing gasket, and the sealing gasket Around the opening, the flexible gasket has a three-dimensional configuration and matches the three-dimensional contour of the sealing gasket to form a double-layer gasket structure.
The flexible gasket according to claim 1, wherein the material of the flexible gasket is elastic fabric, or PU sponge, or a composite material of elastic fabric and sponge, or a composite material of elastic fabric and PU film, or Adhesive layer, PU sponge layer and elastic fabric provided for stacking.
The flexible pad according to claim 2, wherein the elastic fabric is a heat-settable elastic fabric, which includes the following components: nylon, Lycra yarn, absorbent fiber, and hot melt yarn.
The flexible gasket according to claim 3, wherein the elastic fabric is an elastic sandwich cloth, and the thickness of the flexible gasket is 0.4-5 mm.
The flexible gasket according to claim 1, wherein the sealing gasket is formed with a bonding area, the sealing gasket is a silicone gasket, and the flexible gasket is used to at least partially cover the bonding area .
The flexible pad according to claim 5, wherein a skin contact area directly contacting the skin is formed on the flexible pad, and the skin contact area and the bonding area at least partially overlap.
The flexible gasket according to claim 5, wherein the surface of the flexible gasket is coated with an adhesive layer, and the flexible gasket is detachably attached to the bonding area through the adhesive layer Above, the adhesive layer is a gel layer or a self-adhesive layer.
The flexible gasket according to claim 1, wherein the flexible gasket includes an annular main body and an annular peripheral edge formed on the peripheral edge of the annular main body, the annular peripheral edge of the flexible gasket is detachably Connected to the casing and surrounding the sealing gasket, the ring-shaped body and the sealing gasket are separated from each other.
The flexible gasket according to claim 8, wherein a groove is formed on the cover, and an elastic member is provided on an annular periphery of the flexible gasket, and the elastic member is detachably snapped on the Described within the groove.
The flexible gasket according to claim 6, wherein the flexible gasket further comprises a rigid snap ring, the rigid snap ring protrudes outwardly around the outer edge of the skin contact area, the hard A ring-shaped frame is convexly arranged on the quality snap ring, and an annular groove is concavely arranged on the cover shell, and the annular groove is wrapped around the outside of the bonding area and is spaced apart from the bonding area. A hard snap ring is sleeved and attached to the side wall surface of the casing, and the ring-shaped frame is detachably snapped into the annular groove to install the flexible gasket on the casing .
The flexible cushion according to claim 1, wherein the flexible cushion is thickened on opposite sides of the nose bridge.
A shell structure for breathing, characterized in that it includes a sealing gasket and the flexible gasket according to claim 1, wherein the sealing gasket is integrally formed on the shell, and one end of the shell is laterally inward The sealing gasket is extended to form an opening around the flexible gasket, the flexible gasket is detachably disposed on the casing and at least partially covers the sealing gasket.
The breathing shell structure according to claim 12, wherein the sealing gasket is a silicone gasket, a bonding region is formed on the sealing gasket, and the flexible gasket at least partially covers the bonding region , A skin contact area directly contacting the skin is formed on the flexible pad.
The respiratory shell structure according to claim 13, wherein the flexible gasket is partially attached and connected to the sealing gasket.
The respiratory shell structure according to claim 14, wherein a nose bridge contact area is formed on the joint area, and the flexible cushion includes an attached portion and a separated portion connected to each other, the attached portion may be Detachably connected to the nose bridge contact area, the separation portion and the bonding area are separated from each other, and the skin contact area is formed on the attachment portion and the separation portion.
The respiratory shell structure according to claim 15, wherein the flexible cushion covers only the nose bridge contact area.
The breathing shell structure according to claim 12, wherein a groove is formed on the shell, an elastic member is provided on an annular peripheral edge of the flexible gasket, and the elastic member is detachably locked Within the groove.
A breathing interface interface, characterized by comprising the breathing shell structure according to any one of claims 12-17.
The respiratory interface interface of claim 18, wherein the respiratory interface interface is a face mask, a nasal mask, or a mask.